Feldene

Piroxicam is also sometimes used to treat gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints) and ankylosing spondylitis (arthritis that mainly affects the spine). It is also sometimes used to relieve muscle pain and swelling, menstrual pain, and pain after surgery or childbirth. Talk to your doctor about the risks of using this medication for your condition.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Feldene

GENERIC AVAILABLE: Yes

The most common side effects of piroxicam are:

• rash,
• headaches,
• dizziness,
• drowsiness,
• abdominal pain,
• nausea,
• constipation,
• fluid retention,
• ringing in the ears, and
• photosensitivity.

NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury.

Piroxicam also may cause stomach and intestinal bleeding and ulcers. Sometimes, stomach ulceration and intestinal bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding. People who are allergic to other NSAIDs should not use piroxicam.

NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.

Individuals with asthma are more likely to experience allergic reactions to prioxicam and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have also been associated with the use of NSAIDs.

Take Feldene exactly as prescribed.

Feldene comes in capsule form. It is taken once or twice daily, with or after food to minimize stomach upset.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Feldene at the same time.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:

Cardiovascular System: Edema

Digestive System: Anorexia, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting

Nervous System: Dizziness, headache, vertigo

Skin and Appendages: Pruritus, rash

Special Senses: Tinnitus

Additional adverse experiences reported occasionally include:

Cardiovascular System: Palpitations

Digestive System: Stomatitis

Nervous System: Drowsiness

Special Senses: Blurred vision

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FELDENE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body As a Whole: Fever, infection, sepsis, anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope, arrhythmia, exacerbation of angina, hypotension, myocardial infarction, vasculitis

Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis

Hemic and Lymphatic System: Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Hypersensitivity: Positive ANA

Metabolic and Nutritional: Weight changes, Fluid retention, hyperglycemia, hypoglycemia

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence,
tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations

Respiratory System: Asthma, dyspnea, respiratory depression, pneumonia

Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction

Special Senses: Conjunctivitis, hearing impairment, swollen eyes

Urogenital System: Abnormal renal function, cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis

Reproductive system and breast disorders: Female fertility decreased

Read the entire FDA prescribing information for Feldene (Piroxicam)

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation.

Piroxicam is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis.

Piroxicam may also be used for purposes not listed in this medication guide.

• Inhibits cyclooxygenase-1 (COX-1) and COX-2.88 89 90 91 92 93

• Pharmacologic actions similar to those of other prototypical NSAIAs;2 4 exhibits anti-inflammatory, analgesic, and antipyretic activity.1 2 4

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of piroxicam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of piroxicam in the elderly. However, elderly patients may be more sensitive to the stomach side effects (eg, ulcers, bleeding) of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving piroxicam.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Ceritinib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Dicumarol
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alacepril
• Anisindione
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cilazapril
• Delapril
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Imidapril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Pentopril
• Perindopril
• Pindolol
• Practolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Temocapril
• Timolol
• Trandolapril
• Valsartan
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Blood clots or
• Congestive heart failure or
• Dehydration or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or
• Heart or blood vessel disease or
• Hyperkalemia (high levels of potassium in the blood) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Stomach or intestinal ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or
• Aspirin sensitivity, history of or
• Kidney disease, severe—Should not be used in patients with these conditions.

• Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bloating
• bloody or black, tarry stools
• burning upper abdominal or stomach pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• headache
• heartburn
• indigestion
• itching skin or rash
• loss of appetite
• nausea or vomiting
• pale skin
• severe abdominal or stomach pain, cramping, or burning
• severe and continuing nausea
• swelling
• swelling of the face, fingers, feet, or lower legs
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight changes

• Bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• clay-colored stools
• confusion
• cough or hoarseness
• dark urine
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty with swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• fainting
• fever or chills
• flushing or redness of the skin
• frequent urge to urinate
• increased sensitivity of the skin to sunlight
• increased thirst
• increased volume of pale, dilute urine
• large, flat, blue, or purplish patches in the skin
• lightheadedness
• lower back or side pain
• nervousness
• noisy breathing
• numbness or tingling in the hands, feet, or lips
• pain or burning in the throat
• peeling of the skin
• pinpoint red or purple spots on the skin
• pounding in the ears
• rapid, shallow breathing
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• severe sunburn
• slow, fast, pounding, or irregular heartbeat or pulse
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach upset
• swelling or inflammation of the mouth
• swollen glands
• tenderness in the stomach area
• tightness in the chest
• unpleasant breath odor
• unusually warm skin
• weakness or heaviness of the legs
• yellow eyes or skin

• Anxiety
• back or leg pains
• burning, dry, or itching eyes
• cold sweats
• coma
• cracks in the skin
• diarrhea
• discharge or excessive tearing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort or illness
• high fever
• increased hunger
• increased urination
• inflammation of the joints
• irregular, fast or slow, or shallow breathing
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of heat from the body
• muscle aches and pains
• nightmares
• no blood pressure
• no breathing
• no pulse
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• scaly skin
• seeing, hearing, or feeling things that are not there
• seizures
• severe headache
• shakiness
• shivering
• sleepiness
• slurred speech
• sneezing
• sores, welting, or blisters
• stiff neck or back
• stomach pain, continuing
• suddenly sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

• Agitation
• depression
• hives
• hostility
• irritability
• muscle twitching
• pain or discomfort in the chest, upper stomach, or throat
• rapid weight gain
• stupor
• swelling of the ankles or hands
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• excess air or gas in the stomach or intestines
• hearing loss
• passing gas
• stomach discomfort or upset

• Feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• lack or loss of strength
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Change in hearing
• changes in appetite
• inability to sit still
• mood alterations
• need to keep moving
• restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Carefully consider the potential benefits and risks of Feldene and other treatment options before deciding to use Feldene. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

After observing the response to initial therapy with Feldene, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of Feldene, steady-state blood levels are not reached for 7–12 days. Therefore, although the therapeutic effects of Feldene are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.

Pregnancy

Risk Summary

Use of NSAIDs, including Feldene, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Feldene, in pregnant women starting at 30 weeks of gestation (third trimester).

There are no adequate and well-controlled studies of Feldene in pregnant women.

Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2–4% for major malformations, and 15–20% for pregnancy loss.

In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the MRHD, respectively. In rat studies with piroxicam, fetotoxicity (postimplantation loss) was observed at exposures 2 times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of piroxicam. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as piroxicam, resulted in increased pre- and post-implantation loss.

Clinical Considerations

Labor or Delivery

There are no studies on the effects of Feldene during labor or delivery. In animal studies, NSAIDS, including piroxicam inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Data

Animal data

Pregnant rats administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days 6 to 15) demonstrated increased post-implantation losses with 5 and 10 mg/kg/day of piroxicam (equivalent to 2 and 5 times the maximum recommended human dose [MRHD], of 20 mg respectively, based on a mg/m2 body surface area [BSA]). There were no drug-related developmental abnormalities noted in offspring. Gastrointestinal tract toxicity was increased in pregnant rats in the last trimester of pregnancy compared to non-pregnant rats or rats in earlier trimesters of pregnancy. Pregnant rabbits administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days 7 to 18) demonstrated no drug-related developmental abnormalities in offspring (up to 10 times the MRHD based on a mg/m2 BSA).

In a pre- and post-natal development study in which pregnant rats were administered piroxicam at 2, 5, or 10 mg/kg/day on Gestation Day 15 through delivery and weaning of offspring, reduced weight gain and death were observed in dams at 10 mg/kg/day (5 times the MRHD based on a mg/m2 BSA) starting on Gestation Day 20. Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero. Parturition was delayed and there was an increased incidence of stillbirth in all piroxicam-treated groups (at doses equivalent to the MRHD). Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity.

Lactation

Risk Summary

Limited data from 2 published reports that included a total of 6 breastfeeding women and 2 infants showed piroxicam is excreted in human milk at approximately 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in maternal plasma during treatment. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Feldene and any potential adverse effects on the breastfed infant from the Feldene or from the underlying maternal condition.

Females and Males of Reproductive Potential

Infertility

Females

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including Feldene, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including Feldene, in women who have difficulties conceiving or who are undergoing investigation of infertility.

Pediatric Use

Feldene has not been investigated in pediatric patients. The safety and effectiveness of Feldene have not been established.

Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3, 5.6, 5.13)].

Feldene (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure.

Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8).

The inactive ingredients in Feldene include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0069-3220-66

Feldene®
(piroxicam)

10 mg

100 Capsules
Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0069-3230-66

Feldene®
(piroxicam)

20 mg

100 Capsules
Rx only

Applies to piroxicam: oral capsule, oral tablet

Along with its needed effects, piroxicam (the active ingredient contained in Feldene) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking piroxicam:

• Bloating
• bloody or black, tarry stools
• burning upper abdominal or stomach pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• headache
• heartburn
• indigestion
• itching skin or rash
• loss of appetite
• nausea or vomiting
• pale skin
• severe abdominal or stomach pain, cramping, or burning
• severe and continuing nausea
• swelling
• swelling of the face, fingers, feet, or lower legs
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight changes

• Bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• clay-colored stools
• confusion
• cough or hoarseness
• dark urine
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty with swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• fainting
• fever or chills
• flushing or redness of the skin
• frequent urge to urinate
• increased sensitivity of the skin to sunlight
• increased thirst
• increased volume of pale, dilute urine
• large, flat, blue, or purplish patches in the skin
• lightheadedness
• lower back or side pain
• nervousness
• noisy breathing
• numbness or tingling in the hands, feet, or lips
• pain or burning in the throat
• peeling of the skin
• pinpoint red or purple spots on the skin
• pounding in the ears
• rapid, shallow breathing
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• severe sunburn
• slow, fast, pounding, or irregular heartbeat or pulse
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach upset
• swelling or inflammation of the mouth
• swollen glands
• tenderness in the stomach area
• tightness in the chest
• unpleasant breath odor
• unusually warm skin
• weakness or heaviness of the legs
• yellow eyes or skin

• Anxiety
• back or leg pains
• burning, dry, or itching eyes
• cold sweats
• coma
• cracks in the skin
• diarrhea
• discharge or excessive tearing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• general feeling of discomfort or illness
• high fever
• increased hunger
• increased urination
• inflammation of the joints
• irregular, fast or slow, or shallow breathing
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of heat from the body
• muscle aches and pains
• nightmares
• no blood pressure
• no breathing
• no pulse
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• scaly skin
• seeing, hearing, or feeling things that are not there
• seizures
• severe headache
• shakiness
• shivering
• sleepiness
• slurred speech
• sneezing
• sores, welting, or blisters
• stiff neck or back
• stomach pain, continuing
• suddenly sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur while taking piroxicam:

• Agitation
• depression
• hives
• hostility
• irritability
• muscle twitching
• pain or discomfort in the chest, upper stomach, or throat
• rapid weight gain
• stupor
• swelling of the ankles or hands
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects of piroxicam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• excess air or gas in the stomach or intestines
• hearing loss
• passing gas
• stomach discomfort or upset

• Feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• lack or loss of strength
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Change in hearing
• changes in appetite
• inability to sit still
• mood alterations
• need to keep moving
• restlessness

Applies to piroxicam: compounding powder, oral capsule

General

The most commonly reported adverse effects are abdominal pain/discomfort, flatulence, nausea, epigastric distress, constipation, diarrhea, dizziness, and headache.[Ref]

Gastrointestinal

Common (1% to 10%): Anorexia, indigestion, abdominal pain/discomfort, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric and duodenal ulcers, vomiting, epigastric distress
Uncommon (0.1% to 1%): Dry mouth, esophagitis, gastritis, glossitis, hematemesis, melena, rectal bleeding, stomatitis
Rare (0.01% to 0.1%): Colic, eructation, pancreatitis
Frequency not reported: Peptic ulceration, gastrointestinal hemorrhage[Ref]

Evidence from observational studies have shown administration of doses greater than 20 mg orally per day increases the risk for gastrointestinal (GI) side effects. This drug may be associated with a high risk of GI toxicity relative to other nonsteroidal anti-inflammatory drugs (NSAIDs). About 1 in 5 patients who develop serious upper GI adverse events due to NSAID therapy are symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients whom are treated for 3 to 6 months and in 2% to 4% of patients treated for 1 year.[Ref]

Renal

Common (1% to 10%): Abnormal renal function
Uncommon (0.1% to 1%): Renal papillary necrosis, glomerulonephritis, interstitial nephritis, nephrotic syndrome, renal failure[Ref]

Renal toxicity while using piroxicam has occurred in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation and secondarily, renal blood flow, which may precipitate overt renal decompensation.[Ref]

Hepatic

Common (1% to 10%): Elevated liver enzymes
Uncommon (0.1% to 1%): Hepatitis, jaundice
Rare (0.01% to 0.1%): Liver failure[Ref]

Significant elevations of the liver enzymes AST and ALT (about 3 or more times the upper limit of normal) have occurred in approximately 1% of patients in clinical trials with nonsteroidal anti-inflammatory drugs (NSAIDs). Borderline elevations have occurred in up to 15% of patients taking NSAIDs, including this drug.[Ref]

Cardiovascular

Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Congestive heart failure, hypertension, tachycardia, syncope
Rare (0.01% to 0.1%): Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis, chest pain
Frequency not reported: Arterial thrombotic events[Ref]

Clinical trials of several COX-2 selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) of up to 3 years duration have shown an increased risk of serious and sometimes fatal cardiovascular thrombotic events, myocardial infarction, and stroke.[Ref]

Dermatologic

Observational studies suggest that piroxicam (the active ingredient contained in Feldene) may be associated with a higher risk of severe cutaneous adverse reactions than other non-oxicam NSAIDs. There is an increased risk early in the course of therapy, with the majority of cases occurring within the first month.[Ref]

Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Alopecia, bruising, desquamation, erythema, photosensitivity,
Rare (0.01% to 0.1%): Toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens - Johnson syndrome, urticaria, vesiculobullous reaction, ecchymosis, petechial rash
Frequency not reported: Non-thrombocytopenic purpura (Henoch-Schonlein)[Ref]

Hematologic

Common (1% to 10%): Anemia, prolonged bleeding time
Uncommon (0.1% to 1%): Eosinophilia, leukopenia, purpura, thrombocytopenia
Rare (0.01% to 0.1%): Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Frequency not reported: Decreased hemoglobin and hematocrit[Ref]

Hypersensitivity

A combination of dermatological/allergic signs and symptoms suggestive of serum sickness have occasionally occurred while using this drug. These include arthralgias, pruritus, fever, fatigue and rash (e.g., vesiculobullous reactions and exfoliative dermatitis).[Ref]

Rare (0.01% to 0.1%): Anaphylaxis, angioedema
Frequency not reported: Serum sickness[Ref]

Metabolic

Common (1% to 10%): Elevated BUN, elevated serum creatinine, anorexia
Uncommon (0.1% to 1%): Weight changes, hyperkalemia, fluid retention
Rare (0.01% to 0.1%): Appetite changes, hyperglycemia, hypoglycemia[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, sedation
Uncommon (0.1% to 1%): Asthenia, drowsiness, malaise, paresthesia, somnolence, tremors, vertigo, amnesia
Rare (0.01% to 0.1%): Akathisia, convulsions, coma, meningitis
Postmarketing experience: Aseptic meningitis[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma, dyspnea, epistaxis
Rare (0.01% to 0.1%): Respiratory depression, pneumonia
Frequency not reported: Bronchospasm[Ref]

Other

Common (1% to 10%): Tinnitus, deafness
Uncommon (0.1% to 1%): Fever
Rare (0.01% to 0.1%): Death, hearing impairment, thirst[Ref]

Endocrine

Rare (0.01% to 0.1%): Female fertility decreased[Ref]

Immunologic

Uncommon (0.1% to 1%): Infections, sepsis
Rare (0.01% to 0.1%): Positive ANA, flu-like syndrome[Ref]

Genitourinary

Uncommon (0.1% to 1%): Cystitis, dysuria, hematuria, oliguria, polyuria, proteinuria, urinary frequency, menorrhagia[Ref]

Local

Rare (0.01% to 0.1%): Sweating[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Conjunctivitis, swollen eyes[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, confusion, depression, dream abnormalities, personality changes
Rare (0.01% to 0.1%): Hallucinations, mood alterations, nervousness
Frequency not reported: Insomnia[Ref]

Some side effects of Feldene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.